France copied research, found that sulfanilamide is a common industrial drug. Kills bacteria. No patent.

1937: Massengill and Co. (Tennessee) marketed liquid for of sulfanilamide. Suspended the drug in anti- freeze (diethylene glycol) because it didn't desolve in water or alcohol. 100's of children were killed.

Term

Food, Drug, and Cosmetic Act

Definition

1938: the FDA were established. It identified and eliminated dangerous drugs by testing their safety. It monitored clinical investigators and facilities to ensure patients' well- being.

Mission: Promote/protect public health; help safe/effective products reach market timely. Monitor products for continued safety after approved and used by consumers. Help public get accurate, science- based info. needed to improve health.

Heart of any judgement based on cost vs. benefit analysis.

6 FDA centers:

Center for safety and applied nutrition.

center for drug evaluation and research. (CDER)

center for biologics evaluation and research. (CBER)

center for veterinary medicine (CVM)

center for devises and radiological health. (CDRH)

national center for toxicological research.

Term

What was the total health expenditure in 2010?

Definition

$2.5 T

Term

Of total health expenditures, what was the percentage of total GDP in 2010?

Definition

17.6%

Term

Of total health expenditures, what was the percentage of public expenditures in 2010?

Definition

48.2%

Term

Of total health expenditures, what was the percentage of pharmaceutical expenditures in 2010?

Definition

12.6%

Term

What was the per capita Total health expenditures in 2010?

Definition

$8,232.90

Term

What was the per capita pharmaceutical expenditures in 2010?

Definition

$983.10

Term

What was medicare spending in 2010?

Definition

$509 B

Term

What was medicaid spending in 2010?

Definition

$389.1 B

Term

What was Rx (prescription) drug retail spending in 2008?

Definition

$234.1 B

Term

Of Rx drug retail spending, what % was of private insurance in 2008?

Definition

42%

Term

Of Rx drug retail spending, what % was of out- of- pocket in 2008?

Definition

21%

Term

Of Rx drug retail spending, what % was of public programs in 2008? Of that, what percentage was of medicare, and medicaid?

Definition

37%

medicare: 60%

medicaid: 25%

Term

Of National Health expenditures, what percentage was of retail/rx drugs in 2010?

Definition

10%

Term

Of National Health expenditures, what percentage was of retail/other products in 2010?

Definition

3%

Term

Of National Health expenditures, what percentage was of government administration in 2010?

Definition

1%

Term

Of National Health expenditures, what percentage was of net cost of health insurance in 2010?

Definition

6%

Term

Of National Health expenditures, what percentage was of other health, residential, and personal care in 2010?

Definition

3%

Term

Of National Health expenditures, what percentage was of investments in 2010?

Definition

6%

Term

Of National Health expenditures, what percentage was of hospital care in 2010?

Definition

31%

Term

Of National Health expenditures, what percentage was of physicians/clinical services in 2010?

Definition

20%

Term

Of National Health expenditures, what percentage was of other professional services in 2010?

Definition

7%

Term

Of National Health expenditures, what percentage was of other professional services in 2010?

Definition

7%

Term

Of National Health expenditures, what percentage was of home health care in 2010?

Definition

3%

Term

Of National Health expenditures, what percentage was of nursing home care in 2010?

Definition

5%

Term

Of National Health expenditures, what percentage was of other health, residential, and personal care in 2010?

Definition

5%

Term

What was the average price in 2008? Of what was percentage was of manufacturers, retailers, and wholesalers?

Definition

$71.69manufacturers: 78%retailers: 17%wholesalers: 4%

Term

What was the average branded price in 2008?

Definition

$137.90

Term

What was the average generic price in 2008?

Definition

$35.22

Term

What was the percentage increase in Rx prices in 2008?

Definition

2.5%

Term

What was the Rx sales in 2009? Of that, what percentage of total Rx generic drugs were sales in 2008? What percentage of total Rx generic drugs were dispensed in 2008?

Definition

$300.3 Bsales: 22%dispensed: 72%

Term

What was the research and development on new medicines and vaccines by pharmaceutical and biotech firms in 2009?